New Machinery Regulation

The New Machinery Regulation (EU) 2023/1230, which replaces the Machinery Directive 2006/42/EC, introduces important updates aimed at addressing technological developments and strengthening safety requirements for machinery placed on the European market.

The regulation was published in July 2023 and will become fully applicable on 20 January 2027. It aims to ensure a higher level of safety while taking into account the increasing use of digital technologies, artificial intelligence, and interconnected machinery systems.

Key Changes Introduced by the Regulation

One of the most significant changes is the transition from a Directive to a Regulation, meaning that the rules will apply directly across all EU Member States without requiring national transposition.

The new regulation also introduces updated requirements for digital documentation and instructions, allowing manufacturers to provide certain documentation in digital form.

In addition, the regulation places stronger emphasis on cybersecurity and safety of software-driven machinery, particularly in relation to machines incorporating artificial intelligence or connected systems.

The classification of high-risk machinery has also been revised, which may require third-party conformity assessment procedures involving a Notified Body for certain categories of machinery.

What This Means for Manufacturers

Manufacturers placing machinery on the EU market should carefully review the new regulatory framework and assess how the updated requirements may affect their products, technical documentation, and conformity assessment procedures.

Early preparation will help manufacturers ensure compliance and avoid disruptions when the regulation becomes fully applicable.

ECES Support

As a Notified Body designated by the European Commission (NB 3078), ECES supports manufacturers in understanding and navigating regulatory requirements related to machinery and other regulated products.

Is Your Technical Documentation Complete?

Machinery safety legislation requires the manufacturer to prepare technical documentation demonstrating that the product complies with the requirements of the applicable directives or regulations.

The legislation sets out general provisions regarding the types of information that must be included in the technical documentation. However, these provisions are formulated in rather general terms.

As general guidance, the technical documentation should include the following elements:

• Description of the machinery
• Electrical connection and circuit diagrams
• General arrangement drawing
• List of applied standards
• Risk assessment records and evaluations carried out in accordance with the relevant standards
• Calculations and test reports
• Instructions for use
• EU Declaration of Conformity

Note: The technical documentation must be kept for 10 years after the machinery has been placed on the market.

Are Your Instructions for Use Compliant?

All machinery must be accompanied by instructions prepared in the official Community language(s) of the Member State in which the machinery is placed on the market and/or put into service.

The instructions provided with the machinery must be either “Original Instructions” or a “Translation of the Original Instructions.”

Where a translation is provided, it must be supplied together with the original instructions.

Instructions form an integral part of the machinery. They must include information and warnings relating to installation, maintenance, safe use, and reasonably foreseeable misuse.

! Any structural or software modification to a machine makes the party carrying out those modifications legally the “Manufacturer.”

The new Machinery Safety Regulation:

• Increases legal certainty through uniform application.
• Includes provisions for machinery whose safety functions are supported by artificial intelligence.
• Integrates cybersecurity requirements for safety-related control systems and software critical to conformity.
• Addresses the conformity assessment of machinery with higher risk factors.
• Updates certain provisions specific to particular product categories.
• Clarifies the conditions under which instructions for use and the declaration of conformity may be provided in digital format.

The new Regulation will replace the current Machinery Directive 2006/42/EC starting in 2027.

The Regulation aims to ensure a high level of protection for workers and consumers by addressing the risks arising from the use of machinery.

With our experts who have extensive knowledge of IEC/TS 63074:2023 and the IEC 62443 standards series, we are here to support you throughout the transition process.